The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
4 other identifiers
observational
100
2 countries
3
Brief Summary
The purpose of this study is to see how beginning or changing anti-HIV medications affects the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle distribution) of HIV-infected children. This study also looks at how changes in body composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts, height, and weight in HIV-infected children. This study also compares changes in body composition to levels of cytokines (proteins in the body that affect some immune cells) in HIV-infected children who are beginning or changing anti-HIV therapy. Though studies have been done on adults, little is known about the effects of HIV infection and anti-HIV drugs on body composition in children. One theory is that changes in body composition can predict the failure of anti-HIV treatment. If this is true, body composition measurements can be as useful as CD4+ cell counts in determining drug effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2000
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 16, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedOctober 29, 2014
October 1, 2014
June 16, 2000
October 28, 2014
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Children may be eligible for this study if they:
- Are 1 month to 12 years old.
- Are HIV-1 positive.
- Have not begun puberty.
- Are beginning or changing anti-HIV therapy and:
- (1) have never used anti-HIV drugs and are starting any anti-HIV therapy; or (2) have never used protease inhibitors (PIs) and are starting a PI-containing therapy; or (3) have used PIs in the past and are changing anti-HIV treatment and have never used at least 2 of the drugs in the new therapy.
- Have a parent or legal guardian able and willing to provide signed informed consent.
You may not qualify if:
- Children will not be eligible for this study if they:
- Have cancer.
- Use metal artificial body parts or electrical devices that have been inserted into the body (such as a pacemaker).
- Have had an arm or leg removed.
- Have a physical disability that would prevent an accurate measurement of body height or length.
- Have diabetes and need insulin.
- Have or have had a serious illness or fever in the 14 days before entering study (except an upper respiratory infection without a fever).
- Have used steroids (corticosteroids, anabolic steroids, or megestrol acetate), interleukin, interferon, thalidomide, or GH within 180 days before entering study. Glucocorticoids are allowed as long as treatment did not occur during the 14 days before entering study and total treatment in the 180 days before entering study was not more than 15 days.
- Have used anti-HIV medication, if they are beginning any anti-HIV therapy.
- Have used PIs, if they are beginning a PI-containing regimen. (Prior use of PIs is allowed if child is changing anti-HIV treatment and he/she has never used at least 2 of the drugs in the new therapy.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
San Juan, PR, 00935, Puerto Rico
Related Publications (4)
Chantry CJ, Hughes MD, Alvero C, Cervia JS, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Insulin-like growth factor-1 and lean body mass in HIV-infected children. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):437-43. doi: 10.1097/QAI.0b013e31817bbe6d.
PMID: 18614924RESULTChantry CJ, Hughes MD, Alvero C, Cervia JS, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy. Pediatrics. 2008 Jul;122(1):e129-38. doi: 10.1542/peds.2007-2467. Epub 2008 Jun 2.
PMID: 18519448RESULTChantry CJ, Cervia JS, Hughes MD, Alvero C, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Predictors of growth and body composition in HIV-infected children beginning or changing antiretroviral therapy. HIV Med. 2010 Oct 1;11(9):573-83. doi: 10.1111/j.1468-1293.2010.00823.x. Epub 2010 Mar 21.
PMID: 20345880RESULTCervia JS, Chantry CJ, Hughes MD, Alvero C, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr, Spector SA; PACTG 1010 Team. Associations of proinflammatory cytokine levels with lipid profiles, growth, and body composition in HIV-infected children initiating or changing antiretroviral therapy. Pediatr Infect Dis J. 2010 Dec;29(12):1118-22. doi: 10.1097/INF.0b013e3181ed9f4c.
PMID: 20631646RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Caroline Chantry
- STUDY CHAIR
Joseph Cervia